Handle remote control for use with bronchoscopy navigation system

ABSTRACT

A surgical system includes an extended working channel, a magnetic field generator, a sensor, a workstation, a computer readable recording medium, and a remote control handle. The extended working channel is sized for insertion into the working channel of a bronchoscope and to receive one or more instruments therethrough. The sensor is associated with a distal end of the extended working channel for detecting a magnetic field generated by the magnetic field generator. The workstation includes a display and is operably connected to the sensor. The computer readable recording medium is associated with the workstation for storing a software program that enables association of the sensed magnetic field with a location of the sensor and that generates one or more images including one or more fields for presentation on the display. The remote control handle enables manipulation of the one or more fields generated by the software.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation of U.S. patent application Ser. No.14/541,240, filed Nov. 14, 2014, now U.S. Pat. No. 9,974,427, the entirecontents of which are hereby incorporated by reference.

BACKGROUND 1. Technical Field

The present disclosure relates to surgical instruments and, morespecifically, to remote controls for bronchoscopy navigation systems.

2. Discussion of Related Art

A common interventional procedure in the field of pulmonary medicine isbronchoscopy, in which a bronchoscope is inserted into the airwaysthrough the patient's nose or mouth. The structure of a bronchoscopegenerally includes a long, thin, flexible tube that typically containsthree elements: an illumination assembly for illuminating the regiondistal to the bronchoscope's tip via an optical fiber connected to anexternal light source; an imaging assembly for delivering back a videoimage from the bronchoscope's distal tip; and a lumen or working channelthrough which instruments may be inserted, including but not limited toplacement (e.g., guide wires), diagnostic (e.g., biopsy tools) andtherapeutic (e.g., treatment catheters or laser, cryogenic, radiofrequency, or microwave tissue treatment probes) instruments. The distaltip of a bronchoscope is steerable. Rotating a lever placed at thehandle of the bronchoscope actuates a steering mechanism that deflectsthe tip in one or more directions.

Bronchoscopies are performed by pulmonologists, also known asbronchoscopists, and are used routinely in the diagnosis and treatmentof conditions such as lung cancer, airway stenosis, and emphysema.Bronchoscopies are typically performed by a staff of at least twopersons: the bronchoscopist and at least one assistant, usually a nurse.During a typical procedure, the bronchoscopist holds the bronchoscopehandle with one hand and the bronchoscope tube with the other hand. Thebronchoscopist guides the distal tip of the bronchoscope and/or otherinstruments by manipulating a proximal end of the bronchoscope tube orthe other instruments.

During insertion and operation of the instruments, images from thebronchoscope and/or other instruments may be viewed by thebronchoscopist on display devices. The settings of the display devicesand/or the images on the display devices may be manipulated by userinterfaces of the display devices. To operate the user interfaces theclinician must remove one hand from the bronchoscope or have anassistant manipulate the user interface. However, the bronchoscope needsto be held steady during insertion and manipulation. Two hands aretypically needed to hold the bronchoscope steady.

These difficulties are exacerbated when tools are passed through theworking channel of the bronchoscope. For example, when inserting biopsytools or using the navigation systems such as the EDGE™ andSUPERDIMENSION™ navigation catheters currently sold by Covidien LP.Indeed these additional tools require one hand just for theirmanipulation. Accordingly, manipulation of a bronchoscope and such anadditional tool requires a second person, particularly to simultaneouslymanipulate the user interface.

Performing a procedure that requires two people is generally moreexpensive and the potential for error is increased. Hence, it isdesirable to modify a procedure so that it may be performed with one ortwo hands, if possible.

SUMMARY

In an aspect of the present disclosure, a surgical system includes anextended working channel, a magnetic field generator, a sensor, aworkstation, a computer readable recording medium, and a remote controlhandle. The extended working channel is sized for insertion into theworking channel of a bronchoscope and to receive one or more instrumentstherethrough. The sensor is associated with a distal end of the extendedworking channel for detecting a magnetic field generated by the magneticfield generator. The workstation includes a display and is operablyconnected to the sensor. The computer readable recording medium isassociated with the workstation for storing a software program thatenables association of the sensed magnetic field with a location of thesensor and that generates one or more images including one or morefields for presentation on the display. The remote control handleenables manipulation of the one or more fields generated by the softwareand presented on the display. The one or more instruments may include alocatable guide that houses the sensor.

In aspects, the remote control handle includes a plurality of directionbuttons to navigate between the one or more fields presented on thedisplay by the software. The remote control handle may include aselection control button enabling selection of one or more optionspresented in the one or more fields on the display by the software.

In some aspects, the remote control handle includes a joystick tonavigate between the one or more fields presented on the display by thesoftware. The joystick may be vertically depressible to enable selectionof one or more options presented in the one or more fields on thedisplay by the software. The system may include a hand selection switchenabling left or right handed operation orienting movements of thesoftware with the selection. The hand selection switch may be disposedon the remote control handle.

In certain aspects, the remote control handle includes a trackball tonavigate between the one or more fields presented on the display by thesoftware. The trackball may be vertically depressible to enableselection of one or more options presented in the one or more fields onthe display by the software. The remote control handle may includeindicia of location on the trackball.

In particular aspects, the remote control handle is in communicationwith the workstation. The communication may be wireless communication.

In certain aspects, the remote control handle is formed at a proximalend of a locatable guide housing the sensor which is insertable into theextended working channel. The proximal portion of the extended workingchannel may include a handle for receiving the remote control handle.The remote control handle and the handle of the extended working channelcan be secured together to fix the relationship of the extended workingchannel to the locatable guide. A portion of the handle of the extendedworking channel is telescopic to enable the fixed locatable guide andthe extended working channel to be advanced in unison.

In aspects, the images are images of lungs of a patient. The softwaremay display a 3D model generated from the one or more images. Thesoftware may generate a pathway to a target and the location of thesensor on that pathway on the one or more images or 3D model forpresentation on the display. The software may enable the presentation ofvideo images from a bronchoscope.

Further, to the extent consistent, any of the aspects described hereinmay be used in conjunction with any or all of the other aspectsdescribed herein.

BRIEF DESCRIPTION OF THE DRAWINGS

Various aspects of the present disclosure are described hereinbelow withreference to the drawings, which are incorporated in and constitute apart of this specification, wherein:

FIG. 1 is a perspective view of an illustrative embodiment of anelectromagnetic navigation system in accordance with the presentdisclosure;

FIG. 2 is an illustration of a user interface of the workstation of FIG.1 presenting a view for performing registration in accordance with thepresent disclosure;

FIG. 3 is an enlarged view of the indicated area of detail of FIG. 1;

FIG. 4 is another embodiment of a handle remote in accordance with thepresent disclosure; and

FIG. 5 is yet another embodiment of a handle remote in accordance withthe present disclosure.

DETAILED DESCRIPTION

Devices, systems, and methods for navigating to a target within aluminal network, for example, a patient's lungs, are provided inaccordance with the present disclosure and described in detail below.The disclosed devices, systems, and methods provide a clinician witheasy to use workflow systems guiding the clinician through the varioussteps involved in performing navigation to a target in the luminalnetwork and improved means of manipulating the workflow or userinterface.

These detailed embodiments are merely examples of the disclosure, whichmay be embodied in various forms. Therefore, specific structural andfunctional details disclosed herein are not to be interpreted aslimiting, but merely as a basis for the claims and as a representativebasis for allowing one skilled in the art to variously employ thepresent disclosure in virtually any appropriately detailed structure.While the following embodiments are described in terms of luminalnavigation of a patient's airways, those skilled in the art will realizethat the same or similar devices, systems, and methods may be used inother luminal networks, such as, for example, the vascular, lymphatic,and/or gastrointestinal networks as well.

With reference to FIG. 1, an electromagnetic navigation (EMN) system 10is provided in accordance with the present disclosure. One such EMNsystem is the ELECTROMAGNETIC NAVIGATION BRONCHOSCOPY® system currentlysold by Covidien LP. Among other tasks that may be performed using theEMN system 10 are planning a pathway to target tissue, navigating acatheter guide assembly to the target tissue, deploying a biopsy toolthrough the catheter assembly into the target tissue to obtain a tissuesample from the target tissue using the biopsy tool, digitally markingthe location where the tissue sample was obtained in a data file relatedto the planned pathway, and placing one or more echogenic markers at oraround the target.

EMN system 10 generally includes an operating table 40 configured tosupport a patient; a bronchoscope 50 configured for insertion throughthe patient's mouth and/or nose into the patient's airways; a trackingsystem 70 including a tracking module 72, a plurality of referencesensors 74, and an electromagnetic field generator 76; a workstation 80including software and/or hardware used to facilitate pathway planning,identification of target tissue, navigation to target tissue, anddigitally marking the biopsy location

FIG. 1 also depicts a catheter guide assembly 100 usable with the EMNsystem 10. The catheter guide assembly 100 includes a handle 91, whichis connected to an extended working channel (EWC) 96. The EWC 96 issized for placement into the working channel of a bronchoscope 50. Inoperation, a locatable guide (LG) 92, including an electromagnetic (EM)sensor 94, is inserted into the EWC 96 and locked into position suchthat the sensor 94 extends a desired distance beyond the distal tip 93of the EWC 96. As shown in FIG. 2, the LG 92 is not quite to the desiredlocation extending beyond the distal end of the EWC 96. The location ofthe EM sensor 94, and thus the distal end of the EWC 96, within anelectromagnetic field generated by the electromagnetic field generator76 can be derived by the tracking module 72, and the workstation 80. Thecatheter guide assembly 100 has a handle 91 that can be manipulated byrotation and compression to steer the distal tip 93 of the LG 92 and theextended working channel 96. An example of a suitable catheter guideassembly is currently marketed and sold by Covidien LP under the nameEDGE™ Procedure Kits. For a more detailed description of the catheterguide assembly 100 reference is made to commonly-owned U.S. ProvisionalPatent Application Ser. No. 62/020,240 filed on Jul. 2, 2014 andentitled System and Method for Navigating within the Lung, the entirecontents of which are hereby incorporated by reference.

As illustrated in FIG. 1, the patient is shown lying on operating table40 with bronchoscope 50 inserted through the patient's mouth and intothe patient's airways. Bronchoscope 50 includes a source of illuminationand a video imaging system (not explicitly shown) and is coupled tomonitoring equipment, e.g., a display 81, for displaying the videoimages received from the video imaging system of bronchoscope 50. Asshown, the display 81 is integrated with and is also the display forworkstation 80; however, it is contemplated that the display could alsobe a separate monitor (not shown).

The catheter guide assembly 100 including LG 92 and EWC 96 areconfigured for insertion through a port 84 formed at the proximal end ofbronchoscope 50 into the patient's airways (although the catheter guideassembly 100 may alternatively be used without bronchoscope 50). The LG92 and EWC 96 are selectively lockable relative to one another via alocking mechanism (not shown). A six degrees-of-freedom electromagnetictracking system 70, e.g., similar to those disclosed in U.S. Pat. No.6,188,355 entitled Wireless Six-degree-of-freedom Locator, and publishedPCT Application No. WO 01/67035 entitled Object Tracking using a SingleSensor or a Pair of Sensors, the entire contents of each of which areincorporated herein by reference, or any other suitable positioningmeasuring system, is utilized for performing navigation, although otherconfigurations are also contemplated. Tracking system 70 is configuredfor use with catheter guide assembly 100 to track the position of the EMsensor 94 as it moves in conjunction with the LG 92 and EWC 96 throughthe airways of the patient, as detailed below.

During procedure planning, workstation 80 utilizes computed tomographic(CT) image data for generating and viewing a three-dimensional model(“3D model”) of the patient's airways, enables the identification oftarget tissue on the 3D model (automatically, semi-automatically ormanually), and allows for the selection of a pathway through thepatient's airways to the target tissue. More specifically, the CT scansare processed and assembled into a 3D volume, which is then utilized togenerate the 3D model of the patient's airways. The 3D model may bepresented on a display 81 associated with workstation 80, or in anyother suitable fashion. Using workstation 80, various slices of the 3Dvolume and views of the 3D model may be presented and/or may bemanipulated by a clinician to facilitate identification of a target andselection of a suitable pathway through the patient's airways to accessthe target. The 3D model may also show marks of the locations whereprevious biopsies were performed, including the dates, times, and otheridentifying information regarding the tissue samples obtained. Thesemarks may also be selected as the target to which a pathway can beplanned. Once selected, the pathway is saved for use during thenavigation procedure. An example of a suitable pathway planning systemand method is described in U.S. patent application Ser. No. 13/838,805entitled Pathway Planning System and Method, filed on Mar. 15, 2014, theentire contents of each of which are incorporated herein by reference.

During navigation, EM sensor 94, in conjunction with tracking system 70,enables tracking of EM sensor 94 as EM sensor 94 is advanced through thepatient's airways. As shown in FIG. 2, view 400 of monitor 81 presents aclinician with a video feed 402 from bronchoscope 50 and a lung survey404 from the planning phase. The lung survey view 400 is one of avariety of screens available to a user when utilizing an EMN navigationsoftware such as that described U.S. Provisional Patent Application Ser.No. 62/020,240, incorporated herein above. Video feed 402 frombronchoscope 50 provides the clinician with a real-time video of theinterior of the patient's airways at the distal end of bronchoscope 50.Video feed 402 allows the clinician to visually navigate thebronchoscope 50 through the airways of the lungs of the patient. Theclinician advances the bronchoscope 50 with the EWC 96 and the LG 92extending therefrom through the airways of the lungs until the real-timeposition of the airways of the lungs of the patient are registered withthe pathway planned during the planning phase. More details regardingthe process of registration are set forth in U.S. Patent Application No.62/020,220 filed Jul. 2, 2014 and entitled REAL-TIME AUTOMATICREGISTRATION FEEDBACK, the entire contents of which are incorporatedherein by reference.

FIG. 2 provides a specific example of one view in a pathway navigationand procedure software. In this view as well as many others provided insuch a software package, before and during the registration process aswell as during the navigation and treatment phases of such systems, theclinician may be required to select tabs on the monitor 81 to select atarget, change tabs, select a navigation plan, activate a navigationplan, manipulate an image (e.g., zoom in and out, or rotate), or provideindicia to the workstation 80 (e.g., “click” a dialog box or choose anoption). As described above, removal of a clinician's hands from thebronchoscope 50 or the catheter guide assembly 100 is required foroperation of such software and making selections, for example on adisplay 81 or necessitates the use of another clinician to fully operatethe system.

Referring to FIGS. 1 and 3, the EMN system 10 includes a handle remote102 that may form the proximal end of the LG 92, and is releasablycoupled to a handle 91 which forms the proximal end of the EWC 96. Thehandle 91 is connected at its distal end to port 84 to the workingchannel of the bronchoscope 50. The handle 91 includes a telescopicportion 86, enabling the LG 92 and EWC 96 to move together through theworking channel of bronchoscope 50. The handle remote 102 is incommunication with the workstation 80 to allow a clinician to interfacewith the workstation 80 without releasing the handle remote 102 or thebronchoscope 50. The handle remote 102 may be wired to the workstation80 or be in wireless communication with the workstation 80. The wirelessconnection may be via radio frequency, optical, WIFI, Bluetooth® (anopen wireless protocol for exchanging data over short distances (usingshort length radio waves) from fixed and mobile devices, creatingpersonal area networks (PANs)), ZigBee® (a specification for a suite ofhigh level communication protocols using small, low-power digital radiosbased on the IEEE 802.15.4-2003 standard for wireless personal areanetworks (WPANs)), etc.

The handle remote 100 includes a proximal end 101 and a distal end 104having a securement device 106. The distal end 104 of the handle remote100 is sized and dimensioned to be received within and releasably coupleto the proximal end of the handle 91. The securement device 106 may be aclip that is received within a slot 97 defined in handle 91 whichrotationally fix the securement device 106 to the handle 91.Alternatively, the securement device 106 may releasably couple thehandle remote 100 to the handle 91 while allowing the handle remote 100to rotate relative to the handle 91.

With particular reference to FIG. 3, the handle remote 100 includes aremote interface 110 having directional controls 112 a-d and a selectioncontrol 114. The direction controls 112 a-112 d allow a clinician tomove a cursor on the display 81 of the workstation 80 in a mannersimilar to an input device such as a computer mouse (e.g., to moveobjects selected about the monitor 81, to select dialog boxes or buttonson monitor 81). Each of the directional controls 112 a-d are orientatedto the display 81 of the workstation 80 (i.e., directional control 112 ais up on the display 81, direction control 112 b is right on the display81, etc.). The selection control 114 allows a clinician to chooseoptions on the monitor 81 (e.g., activate a dialog box, select a plan,or mark a point on the display 81). The selection control 114 mayperform operations on the display 81 similar to operations performed bya left mouse click. It is contemplated that the remote interface 110 mayinclude an option control (not shown) that performs operations on thedisplay 81 similar to operations performed by a right mouse click.

The remote interface 110 may be sized and configured to be gripped bythe hand of a clinician during manipulation of the handle 102. Thehandle remote 102 may include a distal ring 108 proximal to thesecurement device 106 to that may prevent accidental disengagement of ahand of a clinician from the handle remote 102 (e.g., the hand of aclinician sliding off of the handle remote 102). In addition, the distalring 108 provides tactile indicia to a clinician to the position of thedistal end 104 of the handle remote 102 to permit the clinician toposition the handle remote within a hand.

With reference to FIG. 4, another handle remote 120 includes proximalend 122 and a distal end 124. Similar to the distal end 104 of thehandle remote 100, the distal end 124 of the handle remote 120 includesa securement device 106 for securing the handle remote 120 to the handle91. The handle remote 120 includes a body 129 and a user interface 130.The body 129 is sized and configured to be gripped by the hand of aclinician during manipulation of the handle 91. The body 129 includes adistal ring 108.

The remote interface 130 is disposed on the proximal end 122 of thehandle remote 120 and includes a directional control 132 that allows aclinician to move a cursor on the display 81 of the workstation 80 in asimilar manner to the direction controls 112 a-d of the remote interface110 detailed above. The direction control 132 is joystick that isconfigured to be engaged by a thumb of a clinician. The directioncontrol 132 may be moveable in any direction or may be limited tomovement in just the X and Y axis (FIG. 4). The directional control 132may include indicia 136 to a clinician to facilitate orientation of theX axis of the directional control 132 with right and left movement ofthe cursor on the display 81 and to orient the Y axis of the directionalcontrol 132 with up and down movement on the display 81. The indicia 136may provide a tactile surface such that a clinician may orientate thedirection control 132 without diverting attention away from the surgicalprocedure. The direction control 132 may be depressible to chooseoptions on the display 81 similar to the selection control 114 of theremote interface 110 detailed above. The direction control 132 mayprovide tactile and/or haptic feedback to the clinician when thedirection control 132 is depressed.

In embodiments, the body 129 may orientate the handle remote 120 in ahand of a clinician such that the X and Y axis of the direction control132 are orientated with movement of a thumb of the hand of the clinician(e.g., when the hand grips the body 129 of the handle remote 120,movement of the direction control 132 to the right moves the cursor tothe right). It will be appreciated that in such embodiments, the handleremote 120 may be right handed or left handed. In some embodiments, theremote interface 130 may include an orientation switch 133 to choosebetween right and left handed operation of the remote handle 120.

With reference to FIG. 5, another handle remote 140 includes a proximalend 142 and a distal end 144. Similar to the distal end 104 of thehandle remote 100, the distal end 144 of the handle remote 140 includesa securement device 106 for securing the handle remote 140 to the handle91. The handle remote 140 includes a body 149 and a remote interface150. The body 149 of the handle remote 140 is similar to the body 129 ofthe handle remote 120 detailed above.

The remote interface 150 includes a direction control 152 in the form ofa trackball. The direction control 152 is operable in a similar mannerto the direction control 132 of remote interface 130. The directioncontrol 152 may be depressible to choose options on the display 81similar to the direction control 132 detailed above. The remoteinterface 150 may include an indicia 156 to provide a tactile surfacesuch that a clinician may orientate the direction control 152 withoutdiverting attention away from a surgical procedure in a similar mannerto indicia 136 detailed above. The indicia 156 may be disposed on theproximal end 142 of the handle remote 140.

While several types of remote interfaces (e.g. remote interfaces 110,130, 150) are shown herein, it is contemplated that the remote interfacemay also be an optical sensor to detect movement of a finger of aclinician over the sensor, a track pad, or a touch screen. It is alsocontemplated that the remote interface may receive voice commands from aclinician to operate the workstation 80.

By providing a handle remote (e.g., handle remote 100, 120, 140) aclinician may manipulate the handle 91 to guide the LG 92 and EWC 96 toa target within a lung of a patient and operate the workstation 80without releasing the handle 91 or the bronchoscope 50. By allowingmanipulation of the handle 91 and the workstation 80 with one hand of aclinician, the clinician can operate the workstation 80 and the handle91 without drawing the clinician's attention away from the monitor 81 ofthe workstation 80. In addition, the number of clinicians for a givenprocedure may be reduced, which in turn reduces the cost of theprocedure.

As used herein, the term “distal” refers to the portion that is beingdescribed which is further from a user, while the term “proximal” refersto the portion that is being described which is closer to a user.Further, to the extent consistent, any of the aspects and featuresdetailed herein may be used in conjunction with any or all of the otheraspects and features detailed herein.

While several embodiments of the disclosure have been shown in thedrawings, it is not intended that the disclosure be limited thereto, asit is intended that the disclosure be as broad in scope as the art willallow and that the specification be read likewise. Any combination ofthe above embodiments is also envisioned and is within the scope of theappended claims. Therefore, the above description should not beconstrued as limiting, but merely as exemplifications of particularembodiments. Those skilled in the art will envision other modificationswithin the scope of the claims appended hereto.

What is claimed:
 1. A surgical system comprising: an extended workingchannel sized for insertion into a working channel of a bronchoscope; aproximal handle secured about a proximal portion of the extended workingchannel and configured to selectively receive an instrumenttherethrough; and a remote control handle configured to interact with aGUI on a display and having a distal portion releasably coupled directlyto the proximal handle of the extended working channel.
 2. The surgicalsystem according to claim 1, further comprising a magnetic fieldgenerator configured to generate a magnetic field.
 3. The surgicalsystem according to claim 1, wherein the remote control handle includesa plurality of directional buttons, the plurality of directional buttonsconfigured to navigate between fields on the display.
 4. The surgicalsystem according to claim 1, wherein the remote control handle includesa selection control button configured to select one or more options onthe display.
 5. The surgical system according to claim 1, wherein theremote control handle includes a joystick configured to navigate betweenone or more fields on the display.
 6. The surgical system according toclaim 5, wherein the joystick is vertically depressible to enableselection of one or more options presented in the one or more fields onthe display.
 7. The surgical system according to claim 5, furthercomprising a hand selection switch configured to enable left or righthanded operation of the remote control handle.
 8. The surgical systemaccording to claim 1, wherein the remote control handle includes atrackball configured to navigate between one or more fields on thedisplay.
 9. The surgical system according to claim 8, wherein thetrackball is vertically depressible to enable selection of the one ormore fields on the display.
 10. The surgical system according to claim9, wherein the remote control handle includes an indicia of location onthe trackball.
 11. The surgical system according to claim 1, wherein theremote control handle is configured to be in wireless communication witha workstation.
 12. The surgical system according to claim 1, wherein theremote control handle and the proximal handle of the extended workingchannel are configured to be secured together fixing the extendedworking channel relative to a sensor of a locatable guide insertedthrough the extended working channel.
 13. The surgical system accordingto claim 1, wherein a portion of the proximal handle of the extendedworking channel is telescopic which enables a sensor of a locatableguide inserted through the extended working channel and extended workingchannel to be advanced in unison.
 14. The surgical system according toclaim 1, further comprising a locatable guide extendable through theextended working channel, the locatable guide having a sensor associatedwith a distal end of the extended working channel, the sensor configuredto locate the distal end of the extended working channel within amagnetic field.
 15. A surgical system comprising: an extended workingchannel sized for insertion into a working channel of a bronchoscope,the extended working channel configured to allow one or more instrumentsto selectively pass through the extended working channel from a proximalend thereof to a distal end thereof; and a remote control handledirectly releasably coupled to a proximal portion of the extendedworking channel, the remote control handle configured to interact with aGUI on a display, the remote control handle having a hand selectionswitch enabling left or right handed operation of the remote controlhandle.
 16. The surgical system according to claim 15, furthercomprising a magnetic field generator configured to generate a magneticfield.
 17. The surgical system according to claim 15, further comprisinga workstation including the display.
 18. The surgical system accordingto claim 15, wherein the remote control handle is movable independent ofa locatable guide inserted through the extended working channel.
 19. Thesurgical system according to claim 15, further comprising a surgicalinstrument received within the extended working channel.